Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07594821

MeDe Study: Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome

Led by Maasstad Hospital · Updated on 2026-06-01

110

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Carpal tunnel syndrome (CTS) causes pain, numbness, or tingling in the hand and wrist due to pressure on the median nerve. This trial evaluates two surgical approaches for adults with CTS: standard surgery releasing only the carpal tunnel, and extended surgery releasing both the carpal tunnel and the Lacertus fibrosus, a ligament higher in the arm that may also compress the nerve. The study aims to find which surgery better reduces symptoms and improves patient outcomes. Participants will be randomly assigned to one of two groups. One group will receive the standard carpal tunnel release surgery, which involves cutting the transverse carpal ligament to relieve nerve pressure. The other group will undergo an extended surgery that also releases the Lacertus fibrosus by making an additional incision near the elbow to decompress the median nerve further. Both procedures are outpatient and done under local anesthesia. During the 12 months after surgery, participants will be followed regularly. Researchers will assess symptoms using the Boston Carpal Tunnel Questionnaire and monitor functional status, pain, sensation, strength, work ability, complications, and quality of life. They will also track if any participants need additional surgery. The study includes physical exams and patient questionnaires throughout the follow-up period to evaluate recovery and treatment effects.

CONDITIONS

Brief Title

MeDe Study: Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Median Nerve Decompression at Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Confirmed carpal tunnel syndrome by EMG or nerve ultrasound
  • Patient chooses surgical treatment for carpal tunnel syndrome
Not Eligible

You will not qualify if you...

  • Previous surgery to decompress the median nerve on the same wrist or forearm
  • Severe thenar muscle atrophy based on clinical exam
  • Simultaneous nerve decompression in the same arm (e.g., cubital tunnel, Guyon, or radial nerve release)
  • Neurological disorders affecting peripheral nerves (e.g., spinal cord injury, muscular dystrophy, dystonia, ALS)
  • Malunion of the distal radius
  • Impaired hand function
  • Pregnancy
  • Inability to complete study forms due to insufficient understanding of Dutch language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

Duration - Outpatient procedure with recovery time varying per participant

Participants undergo surgery to relieve pressure on the median nerve. They receive either carpal tunnel release alone or combined carpal tunnel and Lacertus fibrosus release.

1 surgery visit (outpatient)

Follow-up

Duration - Up to 12 months

Participants are followed for up to 12 months after surgery to monitor symptoms, function, complications, and quality of life.

Regular follow-up visits up to 12 months after surgery

Trial Site Locations

Total: 2 locations

1

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands, 3079 DZ

Actively Recruiting

2

Spijkenise Medisch Centrum

Rotterdam, South Holland, Netherlands, 3201 GZ

Actively Recruiting

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Research Team

S

Sebastian Poggio Voormolen, BSc, PhD candidate

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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